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Just like your car, a computer needs a little bit of maintenance every so often to keep it running smoothly. One task most often overlooked is defragmenting the h

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ard drive. Just what is hard drive defragmenting, and why should you do it?

What Is File Fragmentation?
Think of your computer's hard disk drive as a large

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

filing cabinet for your data. Every folder in the cabinet represents a file, and the papers filling the folder represent the bytes of data that make up the file.

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

In order to ensure fast access to your papers, you want to keep the folders at the front of the filing cabinet full, so they can be pulled from as quickly as po

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

sible. Let's say, however, that when you get a new bunch of paperwork, you completely fill up the folder, have more folders of papers to store, and the folders ne

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

xt to it are full as well. In most filing systems, the extra paperwork is moved to another cabinet and a note left in the original folder as to where the overstoc

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

k is stored.

Your computer works in much the same way. Space is allocated on the hard drive to keep each file. To keep your computer running smoothly, files are

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ften stored right next to each other in the first available space. However, if you go back and add a few pages to that story you were writing, the computer doesn'

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

t see any space on the hard drive to store the new data. Therefore, it moves the new data into the next available spot on the hard drive and leaves itself a "note

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

" of sorts as to where the rest of your file is. This splitting of the file into separate pieces is known as "file fragmentation".

Why should I Defragment My Har

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

Drive?
As more and more files become more and more fragmented, the longer it takes your computer to access these files, whether you're opening, editing, or

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

even deleting them. If we revisit our filing cabinet analogy, when someone requests the entire stock of a certain folder, the filing employees may have to visit

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

3-4 different folders to fill the order. This same exact thing is happening on your hard drive.

What Does Defragmenting My Hard Drive Do?
The disk defragme

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ntation process takes all the pieces of a file and puts them back together in one single spot on the hard drive. Additionally, your file is moved toward the front

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

of the drive so that it can be accessed faster.

How Often Do I Need to Defragment My Hard Drive?
This depends on how you use your computer. If you access a

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

lot of large files on a frequent basis, chances are your files will fragment more quickly than someone who only checks his e-mail a couple of times a week. Gener

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ally speaking, the average home user should defragment his or her hard drive 4-6 times per year (which is every 2-3 months).

How Do I Defragment My Hard Drive?

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

> On Windows, you right click on the drive you wish to defragment, and select properties and click on the “tools” tab. The second option is to defrag now. Click

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

on this and prepare to wait a while. Depending on the size of your drive and the speed of your computer it may take from thirty minutes to a couple of hours.

It

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

will be worth the wait though. If you have not defragmented your hard drive in a long time, you will be pleasantly surprised at how much quicker your computer is

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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